The Certified Medical Device Auditor is a professional who understands the principles of standards, regulations, directives, and guidance for auditing a medical device system while using various tools and techniques to examine, question, evaluate, and report on that system's adequacies and deficiencies.
A medical device auditor analyzes all elements of the system and reports on how well it adheres to the criteria for management and control of process safety.
Candidates must have worked in a full-time, paid role. Paid intern, co-op or any other course work cannot be applied toward the work experience requirement.
Years of on-the-job experience in one or more areas of the Certified Medical Device Auditor Body of Knowledge.
*Year of on-the-job experience must be in a "Decision-making" position.
*A "Decision-making" position is defined as the authority to define, execute, or control projects/processes and to be responsible for the outcome. This may or may not include management or supervisory positions.
Candidates who have completed a degree from a college, university or technical school will have part of the five-year experience requirement waived, as follows (only one of these waivers may be claimed):
Associate degree — one year waived
Bachelor's degree — three years waived
Master's or doctorate — four years waived
Prepare for the exam
Review a list of references that provide the basis for the exam questions. These items give you a better idea of the material covered in the exam. ASQ offers many books and training opportunities to help you prepare.
Each candidate is required to pass an exam that consists of multiple-choice questions that measure comprehension of the Body of Knowledge.
Computer Delivered - The CMDA examination is a one-part, 145-multiple choice question exam, and is offered in English only. 135 questions are scored and 10 are unscored. Total appointment time is four-and-a-half-hours, exam time is 4 hours and 18 minutes.
Paper and Pencil - The CMDA examination is a one-part, 135- multiple choice question, four-hour exam and is offered in English only.
All examinations are open book. Each participant must bring his or her own reference materials. Use of reference materials and calculators is explained in the FAQs.
If taking the exam CBT you will get your result immediately after submitting the exam. Within 3-5 business days you will receive an email confirming the result. ASQ will mail your hardcopy certificate. Delivery estimates for your certificate are 1-2 weeks (US & Canada), 6-8 weeks (International mailing).
ASQ communicates exam results for exams with updated or new Bodies of Knowledge (pilot exams) within five weeks.
If you do not pass your CBT exam you will receive a summary of your performance via email within 3-5 business days from your initial exam. For 2 years from your previous attempt you can apply at a significantly reduced "retake rate". (Please see Exam Results FAQs for additional details.)
Results for Paper-based tests will be slightly delayed.
Included in the Body of Knowledge are subtext explanations and corresponding cognitive levels for each subtopic. These details will be used by the Examination Development Committee as guidelines for writing test questions and are designed to help candidates prepare for the exam by identifying specific content within each topic that may be tested.
The subtext is not intended to limit the subject matter or be all-inclusive of what might be covered in an exam, but is intended to clarify how topics are related to the role of the certified medical device auditor. The descriptor in parentheses at the end of each subtext entry refers to the highest cognitive level at which the topic will be tested. A more complete description of cognitive levels is provided at the end of the document.
Please Note: The Certified Biomedical Auditor (CBA) program recently underwent a Body of Knowledge refresh and has been renamed to the Certified Medical Device Auditor (CMDA). Please read our Body of Knowledge Map that details the refresh process, and the differences between the 2012 CBA BoK and 2020 CMDA BoK.
Download the Certified Medical Device Auditor Body of Knowledge
All computer-based exams feature a basic scientific calculator on-screen in the exam. Prometric Test Center Administrators can provide you with a hand-held basic calculator upon request.
Any silent, hand-held, battery-operated calculator with no programmable memory will be permitted. Programmable calculators tend to have graphing capabilities, the ability to store text/alphanumeric data by the input of the user, and a function (fn, F1, F2, etc.) button.
Calculators such as the Texas Instruments TI-89 or similar are absolutely not allowed because they are programmable.
Prometric will provide you scratch paper and pencils.
All ASQ exams are open book and all reference materials (including all forms of notes) must be bound and remain bound during the exam.
Bound refers to material permanently bound by stitching or glue and materials fastened securely in its cover by fasteners, which penetrate all papers (i.e., ring binders, spiral binders, plastic snap binders, brads, or screw posts).
Manually or hand-stapled documents that are not securely fastened in their covers are not allowed.
Before you enter the exam room, the Test Center Administrator (TCA) will inspect all references. "Post-Its" will be permitted as book tabs only (must be attached prior to entering the test center).
If you wish to change your exam appointment date or time, you must do so at least five days prior to your appointment using the Reschedule/Cancel option on Prometric's website, or by contacting Prometric's automated voice response system. There is a $100 fee for changing an appointment. Failure to appear for your exam appointment will result in a loss of all applications fees.
Items strictly prohibited in the exam area: hand-stapled materials, blank writing tablets or tablets containing blank pages, unbound tablets, unbound notes, slide charts and/or wheel charts (hand-held cardboard or plastic calculating devices with rotating or sliding pieces).
Application Process & Timeline
1. Submit your application:
Application review takes 1-2 business days for online applications and 3-5 for hardcopy applications.
2. ASQ Review:
After ASQ completes the review process you will receive an approval notification via email or a "hold" message explaining that more information is needed for your application to be approved. If it is determined that you do not meet exam requirements, you will receive a refund minus a $100 processing fee.
3. Testing Options
a. Computer-Based Testing, CBT:
1-2 business days after you receive your approval notification, you will receive an eligibility email containing instructions on how to schedule your exam with our testing provider Prometric.
b. Paper-Based Testing, PBT:
If you have registered for a Paper-based or translated exam you will not receive an eligibility email. Instead you will receive a seating letter with your exam date, time, and location approximately 2 weeks before your exam date.
4. Schedule your exam with Prometric:
Schedule your exam appointment in the testing window you chose at the time of application.